Overview

This trial is active, not recruiting.

Conditions heart failure, ventricular dysfunction, cardiomyopathy
Treatment wireless cardiac stimulator implant to pace the left ventricle for crt
Phase phase 1/phase 2
Sponsor EBR Systems, Inc.
Start date February 2011
End date April 2012
Trial size 100 participants
Trial identifier NCT01294527, EBR-00980

Summary

The WiCS-LV system is an alternative means to providing left ventricular stimulation for Cardiac Resynchronization Therapy (CRT). The purpose of this study is to evaluate the safety and performance of the WiCS-LV System in patients with indications for CRT.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Endpoint classification safety study
Intervention model single group assignment
Masking open label
Primary purpose treatment
Arm
(Experimental)
Implant of the WiCS-LV system
wireless cardiac stimulator implant to pace the left ventricle for crt WiCS-LV system
Transvascular endocardial implantation of wireless pacing Electrode and subcutaneous implantation of Implantable Pulse Generator

Primary Outcomes

Measure
Number of patients with device-related adverse events as a measure of safety
time frame: 24 hour peri-operative and one month
Number of patients with procedure-related adverse events as a measure of safety
time frame: 24 hour perioperative and one month
Bi-ventricular pacing capture
time frame: one month

Secondary Outcomes

Measure
Number of patients with device-related adverse events as a measure of safety
time frame: 6 months
Number of patients with serious adverse events as a measure of safety
time frame: 6 months
Left ventricular pacing capture
time frame: 1, 3, and 6 months
Bi-ventricular pacing capture
time frame: 3 and 6 months
Bi-ventricular pacing capture
time frame: 1, 3, and 6 months
Clinical composite score
time frame: 6 months
Change in echocardiographic indices
time frame: 6 months
Change in blood laboratory Brain Natriuretic Peptide
time frame: 6 months

Eligibility Criteria

Male or female participants at least 18 years old.

Inclusion Criteria: Patients with standard indication for CRT based upon the most recent guidelines AND meeting criteria for one of these three categories: 1. Patients with previously implanted pacemakers or ICD's and meeting standard indications for CRT - referred to as "upgrades" 2. Patients in whom attempted coronary sinus lead implantation for CRT has failed - referred to as "untreated" 3. Patients with previously implanted CRT device, not responding to CRT (no change or worsening of symptom or NYHA functional class after 6 months of treatment confirmed by investigator) - referred to as "non-responders" Exclusion Criteria: 1. Inability to comply with the study follow-up or other study requirements 2. Contraindication to heparin 3. Contraindication to both chronic anticoagulants and antiplatelet agents 4. Contraindication to iodinated contrast agents 5. Intracardiac thrombus by transesophageal echocardiography 6. Age less than 18 years 7. Attempted IPG implant within 3 days 8. Life expectancy of < 12 months 9. Chronic hemodialysis 10. Myocardial infarction within one month 11. Major cardiac surgery within one month 12. Female of childbearing potential, pregnant, or breastfeeding 13. Noncardiac implanted electrical stimulation therapy devices

Additional Information

Official title Multicenter, Prospective Evaluation of Performance, Safety, and Surveillance of the WiCS-LV System in Patients Indicated for Cardiac Resynchronization Therapy
Principal investigator Angelo Auricchio, MD
Description Eligible patients will undergo an acoustic window assessment using transthoracic echocardiography. Patients with adequate acoustic windows will undergo implantation of the WiCS-LV system. Patients will undergo evaluations pre-hospital discharge, and at one month, 3 months, and 6 months post implantation. Extended follow-up will be obtained via a registry at 1, 2, 3, 4, and 5 years post implantation.
Trial information was received from ClinicalTrials.gov and was last updated in November 2015.
Information provided to ClinicalTrials.gov by EBR Systems, Inc..